Key Takeaways
Introduction
In recent years, plaintiffs have increasingly set their sights on kratom, a controversial botanical supplement, as a target for litigation. With at least 15 putative class-action cases filed in the past year alone, this Update explores the background and driving forces behind this growing trend in dietary supplement litigation.
What Is Kratom?
Kratom is a psychoactive compound that has gained popularity over the past decade and is marketed with several purported uses, such as a pain reliever, a treatment for opioid withdrawal, and an antianxiety supplement. In 2018, then-FDA Commissioner Scott Gottlieb announced there was no scientific evidence that kratom was safe or effective for any medical use. More recently, federal and state officials have raised additional concerns about kratom’s potential for addiction and its withdrawal symptoms, which include irritability, anxiety, depression, and physical discomfort.
Kratom at the Federal Level
No food, dietary supplement, or drug containing kratom is lawful at the federal level. The FDA considers kratom an unapproved new dietary ingredient, which means it cannot be lawfully sold as a dietary supplement or food additive in the United States. To enforce these regulations, the FDA has issued several import alerts—most recently in July 2023—permitting the agency to detain and seize kratom imports from specific companies without physical inspection. The FDA has also taken action against kratom products manufactured domestically, including the seizure of approximately $3 million worth of kratom from an Oklahoma-based company in April 2023.
Kratom-Related Litigation
At least 15 consumer class actions were filed in the last year alone against companies manufacturing or selling kratom. These cases generally allege that kratom products are not safe to consume. For example, two recent cases filed in California federal courts allege that the manufacturer falsely and deceptively marketed its kratom powder and capsule products as safe, natural supplements while failing to disclose their highly addictive, opioid-like properties. The complaints assert that the products can cause serious physical and psychological harm, including addiction and withdrawal, and that the company intentionally omitted these material facts from its packaging and advertising.
Recent opinions also underscore potential litigation risks in marketing kratom products. In J.J. v. Ashlynn Mktg. Grp., Inc., the U.S. District Court for the Southern District of California addressed claims under California consumer protection statutes. Plaintiffs alleged that they were unaware of kratom's addictive potential when they began using the kratom product, arguing the product's packaging and advertising failed to disclose this information. In a September 2024 opinion, the court concluded that the plaintiffs had sufficiently alleged theories of fraud as to avoid an early dismissal.
Similarly, the U.S. District Court for the Northern District of California narrowed claims in M.A. et al. v. Thang Botanicals, Inc. Plaintiffs there alleged that the challenged kratom products were highly addictive and lacked adequate addiction warnings. In March 2025, the court initially allowed the case to survive past early dismissal on alleged omissions on the product packaging but required plaintiffs to amend their complaint to conform their allegations with the court’s ruling by April 15, 2025. Plaintiffs failed to comply, leading to an involuntary dismissal of the case on April 30.
Takeaways
In summary, the surge in litigation underscores the growing legal and compliance risks to manufacturers, distributors, and retailers of kratom. Takeaways for the industry include:
- Monitoring ongoing litigation involving kratom to stay ahead of emerging legal risks
- Staying informed on legal and regulatory developments to proactively adapt business practices in this evolving regulatory space
- Addressing regulatory uncertainty by consulting legal counsel and updating compliance protocols regularly
Ultimately, all participants in the kratom industry should closely monitor ongoing legal developments and proactively strengthen their compliance and risk management strategies to navigate this landscape.
[View source.]
